Abstract
As oligonucleotide therapeutics continue to gain traction as a powerful class of gene-modulating agents, protecting these innovations through strategic patenting has become critical. This article explores practical, layered approaches to securing intellectual property for oligonucleotide-based drugs under U.S. patent law. It outlines claim strategies across multiple levels of protection—from broad hot spotand footprint claims to narrower sequence-specific and picture claims—while also addressing platform technologies, conjugates, product formulations, and methods of treatment.
In addition to claim construction, the article offers guidance on navigating key patentability challenges including novelty, non-obviousness, and adequate disclosure, with special consideration for the impact of prior art and the enablement standard. By aligning legal strategy with scientific development, this resource helps researchers, legal professionals, and biotech companies build strong, defensible IP portfolios in the increasingly competitive oligonucleotide therapeutics space.
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